Rhabdomyolysis and/or Creatine Kinase Laboratory Results Following New Use of Statins or Angiotensin-Converting Enzyme Inhibitors

Project Title Rhabdomyolysis and/or Creatine Kinase Laboratory Results Following New Use of Statins or Angiotensin-Converting Enzyme Inhibitors
Date Posted
Thursday, March 1, 2018
Project ID
cder_mpl1r_wp001_nsdp_v01
Status
Complete
Deliverables
Description

These reports contain the estimated rates of inpatient rhabdomyolysis and/or creatine kinase (CK) laboratory results following new use of statins or angiotensin-converting enzyme (ACE) inhibitors. Data from January 1, 2006 to December 31, 2015 from 11 Data Partners contributing to the Sentinel Distributed Database (SDD) were included in this report. This request was distributed on February 19, 2016.

Medical Product
angiotensin-converting enzyme (ACE) inhibitor
statin
Health Outcome
creatine kinase laboratory result
rhabdomyolysis
Population / Cohort
Individuals 22 years of age and older
Time Period
January 1, 2006 - December 31, 2015
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER